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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: manfredhasler who wrote (14691)	9/17/2000 8:36:52 AM
From: Robert K.	Respond to of 17367

Manfred, no the "hero doctors" you mention are the doctors providing "critiical commentary". Apparently even their "critical commentary" states that bpi may indeed work. The hero doctors are the ones that have seen this terrifying disease firsthand, been unable to do much about it (prior to bpi), and are going to appeal the FDA to demand its availability(even in the face of criticism). THEY, are fighting for the kids. You can claim they are fighting for the recognition, but I doubt it. You can claim I am fighting for the money (but that isnt the case). You see, if bpi was for weight loss, or some other non life threatening disease i wouldnt care less. I would be supporting almost EVERYTHING cacatios has said(less the inaccuracies). Fact is FDA is wrong to withhold this drug, and the Kids are the damaged party. Let the expert panel hear the case. I am all for that.

To: manfredhasler who wrote (14691)	9/17/2000 9:12:04 AM
From: aknahow	Read Replies (2) \| Respond to of 17367

Manfred, in the U.K. there has been a massive p.r. campaign for years to get parents to recognize the signs of meningococcemia as early as possible and to seek treatment. The bottle or glass test, is part of this campaign and something I wish had been incorporated into U.S, health awareness. For years any and almost all comments in the u.k. media, including journals cooperate with this effort by stressing the importance of parental education. The doctors who worked on the trial and wrote the paper, should not in any way be denigrated for cooperation with this effort. In fact there is much to be said for this effort continuing even when an absolute cure is found for meningococcemia. The best drug will do no good if parents procrastinate and think it is the flu, or a cold.

To: manfredhasler who wrote (14691)	9/17/2000 12:53:45 PM
From: Cacaito	Read Replies (1) \| Respond to of 17367

Manfred, the "informed consent" FIRST was a MUST as per the Institutional Review Boards (USA) and Ethical committes or any similar name in Europe, and FDA/EU regulators mandate, there is no way around that. The researchers design the study with that in mind. IT IS A LOGISTICAL NIGHTMARE. I have participated as a clinician in at least a dozen studies, some need IRBs, some not, and even almost completely seemingly none harmful studies like my last one on breastfeeding practices, the IRB was consulted and they REQUIRED informed consent JUST FOR PHONE CALLS. I am right now recruting patients for a large institution, for hypothermia treatment of perinatal asphyxia, the first few hours are critical, last subject took 5 hours to get to study site (in the same city) and qualified for just one hour, obviously the result is not the same if done in the first hour. The condition is operant for placebo too. No way it will be try without full informed consent. Maybe Europe is different, not much, since about 75% of patients in this study were from the UK. Commercial reasons, a desperate company cut the study short, The DSMB (data safety monitoring board) suggested 4 times to continue the study, xoma stopped cause they did not have more MONEY. This is part of the reason many in this thread cry FDA did it. Well, it is reality. Your solution will never happened.